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Sponsor: Ottawa Hospital Research Institute
Conditions: Total Hip Arthroplasty
Interventions: Total hip replacement with titanium shell and CORAIL stem, Total hip replacement with Modular Titanium Femoral Stem
Countries: Canada
The main goal is to prospectively evaluate bone mineral density adjacent to the femoral component and femoral bone remodeling of two different designs: CORAIL impaction broach titanium stem compared to a modular titanium femoral stem (Tri-lock). Patients will be randomized to one of the two treatment groups prior to surgery. Each patient will be evaluated at their regularly scheduled 10-14 days, 3, 6, 12 and 24 month visits following surgery. Patients will be asked to have bilateral DEXA bone mineral density tests (10-14 days post-surgery, and 6, 12 and 24 months post-operatively). Urine and serum samples (measures of bone turnover) will be collected at 3, 6 and 12 months post-operatively after an overnight fast. Patient reported questionnaires will be completed preoperatively and at the 3, 6, 12, and 24 month visits.
Sex: ALL
Age: 18 Years to 74 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Patients who are undergoing primary hip surgery for osteo/degenerative arthritis (does not include traumatic arthritis, congenital hip dysplasia, or avascular necrosis). * Patients who are skeletally mature, as determined by Risser sign or at least 18 years of age * Patients under 75 years of age * Patients for whom there is a reasonable expectation that they will be available for each examination scheduled over a two year post-operative follow-up period. Exclusion Criteria: * Patients with previous fusions, acute femoral neck fractures and above knee amputations. * Patients with evidence of active local infection * Patients with neurologic or musculoskeletal disease that may adversely affect gait or weight-bearing. * Patients who have previously undergone an ipsilateral hemi resurfacing, total resurfacing, total bipolar, unipolar or total hip replacement device, or any prior hip surgery or retained internal fixation. * Patients who are anticipated to require contralateral hip surgery in the next year * Patients with known disorders of bone metabolism, systemic inflammatory disorders, and use of drug medications, including oral steroids, HRT, Tamoxifen, calcium, or vitamin D in the past year, and any past bisphosphonate therapy. * Patients with a Body Mass Index (BMI) \> 35 * Patients with neuropathic joints * Patients with severe documented psychiatric disease * Patients requiring structural bone grafts * Patients with an ipsilateral girdlestone * Patients with sickle cell disease * Patients with major acetabular bone stock deficiency
- Ottawa, Ontario, Canada